BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Check against the official notice below — it lists the full affected range.
Biomet, Inc. is recalling approximately 230,001 units of BIOMET StageOne Knee Femoral Cement Spacer Mold (70 MM, Silicone, Sterile, Item 432170) due to a potentially insufficient cleaning process or potential inadequate monitoring of cleaning parameters. The recalled products were distributed worldwide and to numerous U.S. states.
The affected products are identified by specific lot numbers provided in the recall notice. The recall record does not specify a remedy or recommended course of action for consumers who may have affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Reason for recall: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. Distribution: Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nev Quantity: 230,001 Lot/code info: ***Lot Numbers*** 606370, 049930, 959120, 036410, 036420, 095910, 096360, 959140, 318800, 527300, 528020, 527270, 527280, 527290, 528000, 528030, 688320, 688330, 729300, 857840, 976970, 976960, 977170, 074640, 074650, 074770, 239280, 239300, 239430, 310090, 310110, 145240, 239310, 367700, 496560, 496410, 496570, 680290, 702490, 749130, 680440, 702480, 782850, 791570, 844540, 914100, 914120, 033300, 074140, 136900, 219950, 219960, 260570, 272180, 324070, 425620, 425630, 436960, 478210, 545180, 545190, 586680, 667620, 667640, 685360, 685370, 708720, 747310, 074080, 074090, 123160, 139830, 139840, 330910, 349740, 393060, 393070, 499300, 531410, 531420, 596830, 596840, 712330, 802370, 802400, 899190, 013170, 090920, 156150, 156160, 252800, 411600, 411610, 434440, 434450, 450650, 509790, 553370, 567570, 567580, 620040, 722670, 789370, 803140, 803130, 007860, 007870, 041330, 132870, 237790, 237780, 207260, 372800, 428310, 548520, 588790, 628750, 689330, 689340, 628740, 771090, 874730, 893860, 058130, 097310, 225910, 274110, 274200, 325490, 325500, 411270, 452260, 579830, 579850, 625600, 643580, 659450, 659460, 731750, 789360, 858280, 270880, 270890, 270900, 270910, 270920, 281060, 281070, 281090, 281080, 392910, 392990, 393000, 458220, 458210, 535770, 535840, 617720, 617620, 617710, 702370, 863600, 863610, 863620, 863590, 993740, 993790, 567400, 567410, 567360, 567380, 567390, 567340, 567370, 569560, 569600, 739040, 567330, 845090, 845080, 845100, 900850, 046330, 046340, 981460, 12
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.